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Recruiting NCT06220396

CArdioMEtabolic Function and Reserve Capacity in Healthy Adults: The CAMERA Study

No phase Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Right Heart Catheterization with Hemodynamics and Limited Echocardiogram, Magnetic Resonance Imaging (MRI), Dual X-ray absorptiometry (DEXA) scan.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: from 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The purpose of this study is to evaluate pulmonary capillary wedge pressure (PCWP) and other hemodynamic measurements at rest and during exercise in healthy volunteers across the age spectrum.

Interventions

  • Procedure Right Heart Catheterization with Hemodynamics and Limited Echocardiogram
    Right Heart Catheterization (RHC) with Hemodynamics and Limited Echocardiogram is an invasive procedure that involves insertion of a catheter through a blood vessel in the neck, groin, or arm to the right side of the heart. Hemodynamic measurements such as the blood pressure inside the veins, heart, and arteries as well as measurements of blood flow and how much oxygen is in the blood will be completed during the catheterization procedure. It is a way to see how well the heart is working during
  • Procedure Magnetic Resonance Imaging (MRI)
    MRI is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in your body. CMR Imaging will assess myocardial structure, function, and fat content. An additional limited MRI sequence of the the abdomen and one sequence in the thigh will be used to evaluate for visceral adipose tissue (VAT) as a measurement of body composition.
  • Procedure Dual X-ray absorptiometry (DEXA) scan
    A DEXA scan measures the amount of fat in the body using an x-ray that measures bone, calcium and fat.

Primary outcome measures

  • Pulmonary Capillary Wedge Pressure (PCWP) at rest [Time frame: Baseline]
  • Pulmonary Capillary Wedge Pressure (PCWP) during exercise [Time frame: Baseline]
Secondary outcome measures (12)
  • Trans-cardiac uptake of free fatty acids (FFA) at rest [Time frame: Baseline]
  • Trans-cardiac uptake of free fatty acids (FFA) during exercise [Time frame: Baseline]
  • Trans-cardiac uptake of glucose at rest [Time frame: Baseline]
  • Trans-cardiac uptake of glucose during exercise [Time frame: Baseline]
  • Trans-cardiac uptake of ketone bodies at rest [Time frame: Baseline]
  • Trans-cardiac uptake of ketone bodies during exercise [Time frame: Baseline]
  • Left ventricular (LV) global longitudinal strain [Time frame: Baseline]
  • Left Atrial (LA) reservoir strain [Time frame: Baseline]
  • Right Ventricular (RV) free wall strain [Time frame: Baseline]
  • Myocardial mass [Time frame: Baseline]
  • Myocardial volume [Time frame: Baseline]
  • Myocardial fat content [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Apparently healthy volunteers are eligible to participate in this study if they are free of symptoms of exertional breathlessness or fatigue and any diagnosis of heart failure.
  • Patients will also be required to have left ventricular ejection fraction (EF) ≥ 50%.
  • Patients discovered to reduced EF or abnormal resting hemodynamics or other pathologic findings previously undiscovered will be considered screen failures and can be replaced by others to reach the goal enrollment.
  • Informed consent were obtained.
  • No history of heart failure.
  • Willing and able to undergo invasive hemodynamic exercise testing, MRI, and other study assessments.

Exclusion criteria

  • Clinically significant symptoms of exertional dyspnea or fatigue in daily life in the opinion of the investigators.
  • Any diagnosis of heart failure
  • Symptomatic coronary artery disease (e.g., patients with chronic angina)
  • Symptomatic valvular heart disease
  • Pulmonary hypertension
  • Cardiomyopathies
  • High output heart failure
  • Pericardial disease
  • Clinically significant chronic lung disease in the opinion of the investigators
  • Anemia (hemoglobin <12 gm/dL in women and <13 gm/dL in men)
  • Estimated glomerular filtration rate ≤30mL/min
  • Pregnant women
  • Any other disorders or problems that would interfere with the ability to participate safely in the study (e.g. psychiatric disorder or substance abuse)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06220396 · 23-007522

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗